Label: INFLAM-X- aconitum napellus, arnica montana, belladonna, bellis perennis, calendula officinallis, chamomilla, echinacea angustifolia, echinacea purpurea, hamamellis virginiana, hypericum perforatum, millefolium, symphytum officinale, zingiber officinale gel
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Contains inactivated NDC Code(s)
NDC Code(s): 35781-0230-0 - Packager: Gensco Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 1, 2013
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- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS
Aconitum Napellus 3X, Arnica Montana 3X, Belladonna 4X, Bellis Perennis 1X, Calendula Officinalis 1X, Chamomilla 1X, Echinacea Angustifolia 1X, Echinacea Purpurea 1X, Hamamelis Virginiana 1X, Hypericum Perforatum 1X, Millefolium 1X, Symphytum Officinale 3X, Zingiber Officinale 1X.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INDICATIONS & USAGE
INFLAM-X PRO is a homeopathic topical analgesic gel that contains the ingredients listed below. Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions.It is an amber colored odorless gel for use externally to control inflammation and reduce pain.
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WARNINGS AND PRECAUTIONS
For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued.
Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.
- PRINCIPAL DISPLAY PANEL
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ACTIVE INGREDIENT
DRUG FACTS PURPOSE Aconitum Napellus 3X-HPUS Neuralgia Arnica Montana 3X-HPUS Healing of Injured Tissue Belladonna 4X-HPUS Inflammation Bellis Perennis TINC-HPUS Bruising and Edema Calendula Officinallis TINC-HPUS Analgesia Chamomilla TINC-HPUS Tissue Healing Echinacea Angustifolia TINC-HPUS Inflammation Echinacea Purpurea TINC-HPUS Inflammation Hamamellis Virginiana TINC-HPUS Hematomas Hypericum Perforatum TINC-HPUS Neuropathic Pains Millefolium TINC-HPUS Wound healing Symphytum Officinale 4X-HPUS Neuropathy and Periostitus Zingiber Officinale Inflammation
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PURPOSE
INFLAM-X PRO is indicated for the temporary relief of inflammation and pain from injuries such as sprains, strains, repetitive use injuries, traumatic edema, general swelling of joints and soft tissue of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe. INFLAM-X PRO is also indicated for the reduction of bruising.
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WARNINGS
WARNINGS
For external use only. Do not ingest INFLAM-X PRO and avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, you should consult a doctor. If a rash develops, you should discontinue use until rash clears. After the disappearance of rash, you can try INFLAM-X PRO again on a test area and monitor the site for additional results. If no rash or redness results, then you can resume use. However, if the rash persists or redevelops, use should be discontinued.
Keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.
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DOSAGE & ADMINISTRATION
Apply a thin layer (1 drop covers an area of skin 2 inches by 2 inches) to the affected area of the skin 3-4 times daily and rub in gently. Applications of less than 3-4 times a day will not produce optimum results. Excess drops may be wiped from the area. Safe to use on children over age of 2 years.
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- QUESTIONS
- INFORMATION FOR PATIENTS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INFLAM-X
aconitum napellus, arnica montana, belladonna, bellis perennis, calendula officinallis, chamomilla, echinacea angustifolia, echinacea purpurea, hamamellis virginiana, hypericum perforatum, millefolium, symphytum officinale, zingiber officinale gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35781-0230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] in 6 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X] in 6 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 4 [hp_X] in 6 mL BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 1 [hp_X] in 6 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 6 mL CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 1 [hp_X] in 6 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 1 [hp_X] in 6 mL ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 1 [hp_X] in 6 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X] in 6 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 1 [hp_X] in 6 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 1 [hp_X] in 6 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 4 [hp_X] in 6 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 1 [hp_X] in 6 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) UREA (UNII: 8W8T17847W) DOCUSATE SODIUM (UNII: F05Q2T2JA0) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35781-0230-0 1 in 1 BOX 1 6 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/17/2010 Labeler - Gensco Laboratories, LLC (831042325) Registrant - Gensco Laboratories, LLC (831042325) Establishment Name Address ID/FEI Business Operations Gensco Laboratories, LLC 831042325 manufacture(35781-0230)
